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Proof-of-concept for a miniaturized shake-flask biopharmaceutical solubility determination by sonic mixing
ID Veseli, Ardita (Author), ID Kristl, Albin (Author), ID Žakelj, Simon (Author)

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Abstract
The solvent volume must be very small to obtain biopharmaceutically relevant drug solubility data with low consumption of the solid sample which is often in low supply during early drug development. However, the adequate and repeatable mixing of a small volume can be challenging. We therefore developed a straightforward technique based on the shake-flask method which employed only sonication for mixing a very small amount of drug in an aqueous solvent at a stable pH and temperature. To test the technique, the solubilities of the model compounds carvedilol, digoxin, propranolol, theophylline, and verapamil were determined. The determined solubility values agreed well with the conventional shake-flask solubility data obtained in our laboratory and previously published literature data. The time necessary for the measurements (24 h), was shown to be similar to the conventional shake-flask method even for the low solubility drugs digoxin and carvedilol. The solubility % pH dependence can be established very well as shown with verapamil and propranolol and confirmed with a pH in-dependent solubility of theophylline.

Language:English
Keywords:pharmacokinetics, physiologically based pharmacokinetic (PBPK) modeling gastro plus modeling, clinical trial simulation(s), bioequivalence, biopharmaceutics classification system (BCS), virtual bioequivalence (VBE)
Work type:Article
Typology:1.01 - Original Scientific Article
Organization:FFA - Faculty of Pharmacy
Publication status:Published
Publication version:Version of Record
Year:2020
Number of pages:Str. 626-631
Numbering:Vol. 75, no. 12
PID:20.500.12556/RUL-141963 This link opens in a new window
UDC:544.351.3:615
ISSN on article:0031-7144
DOI:10.1691/ph.2020.0063 This link opens in a new window
COBISS.SI-ID:40934147 This link opens in a new window
Publication date in RUL:13.10.2022
Views:1056
Downloads:31
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Record is a part of a journal

Title:Pharmazie
Shortened title:Pharmazie
Publisher:Verlag Volk und Gesundheit
ISSN:0031-7144
COBISS.SI-ID:1720079 This link opens in a new window

Secondary language

Language:Slovenian
Keywords:biofarmacija, farmakokinetika, modeliraje, simulacije kliničnih poskusov, bioekvivalenca

Projects

Funder:ARRS - Slovenian Research Agency
Project number:P1-0189-2018
Name:Farmacevtska tehnologija: od dostavnih sistemov učinkovin do terapijskih izidov zdravil pri otrocih in starostnikih

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